First At-Home HIV Test Approved by FDA

The FDA approved the first at-home HIV test this past Tuesday. The OraQuick test, manufactured by OraSure, uses a mouth swab to provide test results within 20 to 40 minutes. Advocates in the HIV/AIDS community are praising the potential effects of the test on lowering infection rates. Transmission rates of HIV can be lowered by as much as 96 percent by administering anti-retroviral drugs to an infected person.

One in five of the 1.2 million HIV positive Americans don’t know they have HIV. Douglas Michaels, the OraSure Chief Executive said to Reuters, “We set out with a clear purpose – to dramatically impact the number of people getting tested for HIV nationwide. Today’s FDA approval of OraQuick brings us much closer to accomplishing that goal.” The New York Times emphasized the importance of in home tests in the normalization of HIV/AIDS, as anonymity has historically been a deterrent to testing.

The test is 99.98% accurate in HIV-negative individuals, but only 92% accurate in HIV-positive test takers; one in twelve test takers could get a false negative result. The FDA has emphasized that the test is not intended to replace medical tests, but rather provides another method. OraSure was also required by the FDA to open a 24 hour call center staffed by trained counselors with information on how to administer the test, as well as resources for counseling, treatment, and further testing.

After the FDA’s approval on Tuesday, OraSure announced that the test would be available in over 30,000 grocery stores, pharmacies, and online retailers by October of this year. The price has not yet been announced.